Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy (DOXY-HF)

Virginia Commonwealth University (VCU)

Status and phase: Terminated; Phase 2

Conditions: Non-ischemic Cardiomyopathy; Systolic Heart Failure (NYHA II-III)

Treatments: Drug: Doxycycline; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01935622

VCU HM14393

Details and patient eligibility

About

Non-ischemic cardiomyopathy and heart failure are highly influenced by the presence of systemic inflammation.

Doxycycline is a FDA-approved drug to treat bacterial infections which also shows powerful anti-inflammatory effects.

In this study we plan to determine the effects of Doxycycline in patients with stable heart failure and non-ischemic cardiomyopathy on peak of aerobic exercise capacity (peak V02) and ventilator efficiency measured with a cardiopulmonary test.

Full description

In this study of Safety and Efficacy of Doxycycline in Patients with Non-Ischemic Cardiomyopathy Population, we will enroll 24 patients with a clinical diagnosis of heart failure and non-ischemic cardiomyopathy (recent imaging study documenting LV ejection fraction <50%, and no history of coronary or ischemic heart disease) in a single-center, randomized, double-blinded, placebo-controlled clinical trial with allocation 1:1:1 to Doxycycline 100 mg twice daily or Doxycycline 20 mg twice daily or Placebo for 2 weeks.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-ischemic cardiomyopathy (LVEF<40%)
• Heart failure NYHA II-III

Exclusion criteria

• Age <18
• Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme [ACE] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
• Hospitalization for worsening HF or acute decompensated HF within the previous 12 months
• History of coronary or ischemic heart disease
• Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD) or coronary revascularization or cardiac surgery
• Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
• Active infection including chronic infection
• Active cancer (or prior diagnosis of cancer within the past 10 years)
• Recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
• Pregnancy
• Inability to give informed consent
• Other conditions limiting completion of cardiopulmonary exercise test or completion of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 3 patient groups, including a placebo group

Doxycycline 100 mg

Experimental group

Description:

Doxycycline 100 mg twice daily for 14 days

Treatment:

Drug: Doxycycline

Doxycycline 20 mg

Experimental group

Description:

Doxycycline 20 mg twice daily for 14 days

Treatment:

Drug: Doxycycline

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo